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Combination Chemotherapy, Bev, RT, and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Genentech, Inc.
Eli Lilly and Company
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00280150
First received: January 19, 2006
Last updated: May 19, 2017
Last verified: May 2017
Results First Received: March 24, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Treatment
Condition: Lung Cancer
Interventions: Biological: bevacizumab
Drug: carboplatin
Drug: erlotinib hydrochloride
Drug: paclitaxel
Radiation: 3-dimensional conformal radiation therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from four institutions between February 2006 and April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 48 participants screened for eligibility, 46 were deemed eligible and went on to treatment, 1 was ineligible, and 1 was initially ruled eligible but the liver functioning tests (LFTs) continued to increase so the PI felt the participant should not be treated.

Reporting Groups
  Description
Cohort 1 Bevacizumab 10 mg + Chemoradiotherapy
Cohort 2 Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy
Cohort 3 Bevacizumab 10 mg + Erlotinib 150 mg + Chemoradiotherapy
Phase II Bevacizumab + Erlotinib 100 mg + Chemoradiotherapy

Participant Flow:   Overall Study
    Cohort 1   Cohort 2   Cohort 3   Phase II
STARTED   5   5   6   30 
Cohort Induction   5   5   6   30 
Consolidation Therapy   2   5   3   0 [1] 
COMPLETED   2   4   1   20 
NOT COMPLETED   3   1   5   10 
Adverse Event                0                1                2                3 
Lack of Efficacy                0                0                0                3 
Physician Decision                0                0                0                1 
Protocol Violation                0                0                0                1 
Withdrawal by Subject                0                0                0                1 
Did not get consolidation therapy                3                0                3                0 
Declining Performance Status                0                0                0                1 
[1] Phase II participants did not receive consolidation therapy.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort 1 Bevacizumab 10 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Cohort 2 Bevacizumab 10 mg + Erlotinib 100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Cohort 3 Bevacizumab + Erlotinib 150 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Phase II Bevacizumab + Erlotinib100 mg + Chemoradiotherapy (carboplatin, paclitaxel, and 3-dimensional conformal radiation therapy)
Total Total of all reporting groups

Baseline Measures
   Cohort 1   Cohort 2   Cohort 3   Phase II   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   5   6   30   46 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      4  80.0%      3  60.0%      3  50.0%      18  60.0%      28  60.9% 
>=65 years      1  20.0%      2  40.0%      3  50.0%      12  40.0%      18  39.1% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      1  20.0%      2  40.0%      3  50.0%      16  53.3%      22  47.8% 
Male      4  80.0%      3  60.0%      3  50.0%      14  46.7%      24  52.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      1   3.3%      1   2.2% 
Not Hispanic or Latino      5 100.0%      5 100.0%      6 100.0%      29  96.7%      45  97.8% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      1  20.0%      0   0.0%      0   0.0%      1   3.3%      2   4.3% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      1  20.0%      2  33.3%      7  23.3%      10  21.7% 
White      4  80.0%      4  80.0%      4  66.7%      22  73.3%      34  73.9% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   5   5   6   30   46 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Dose of Erlotinib When Given Together With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy (Phase I [Closed to Accrual as of 1/3/2008])   [ Time Frame: 6 weeks after completion of therapy ]

2.  Primary:   Safety and Toxicity Profile of Combining Both Bevacizumab and Erlotinib Hydrochloride With Carboplatin, Paclitaxel, and Thoracic Conformal Radiotherapy   [ Time Frame: 6 weeks after completion of therapy ]

3.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: 5 years ]

4.  Secondary:   Response Rate to Induction Therapy (Phase I [Closed to Accrual as of 1/3/2008] and II)   [ Time Frame: 5 years ]

5.  Secondary:   Overall Response Rate and Survival Profile   [ Time Frame: 5 years ]

6.  Secondary:   Feasibility and Tolerability of Administering Consolidation Therapy   [ Time Frame: 6 cycles ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robin V. Johnson
Organization: UNC Lineberger Comprehensive Cancer Center
phone: 919-966-1125
e-mail: Robin_V_Johnson@med.unc.edu


Publications of Results:

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00280150     History of Changes
Other Study ID Numbers: LCCC 0511
UNC IRB 05-2091
Study First Received: January 19, 2006
Results First Received: March 24, 2017
Last Updated: May 19, 2017